CHMP gives positive opinion on Myozyme

Published: 20-Feb-2009

Genzyme, a biotechnology company based in Cambridge, Massachusetts, says the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on its variation to produce Myozyme (alglucosidase alfa) at the 4,000 litre (L) bioreactor scale at its manufacturing facility in Geel, Belgium.


Genzyme, a biotechnology company based in Cambridge, Massachusetts, says the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on its variation to produce Myozyme (alglucosidase alfa) at the 4,000 litre (L) bioreactor scale at its manufacturing facility in Geel, Belgium.

The positive CHMP opinion is the final step before formal approval to produce and market Myozyme, which is manufactured in the EU, Norway and Iceland.

Myozyme is the only approved treatment for Pompe disease, a progressively debilitating disease that manifests as a broad spectrum of clinical symptoms. All patients typically experience progressive muscle weakness and breathing difficulty, but the rate of disease progression can vary widely depending on the age of onset and the extent of organ involvement.

The CHMP acted quickly on the application due to the current constraints on supply. The 4000 L manufacturing process is expected to help provide adequate supply of Myozyme in Europe for the foreseeable future.

The committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorisation.

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